The FDA granted marketing approval to Genzyme’s Epicel™ (cultured epidermal autografts) product under the Humanitarian Device Exemption (HDE) for the treatment of life-threatening wounds resulting from severe burns. According to Genzyme, Epicel can provide permanent skin replacement for burn victims and is made from a patient's own skin cells and then grown on a layer of mouse cells to enhance growth.
Epicel is the first xenotransplantation-classified product to be approved in the U.S. because of its inclusion of animal cells, notes the company.
Epicel has been used in more than 1,000 patients with burn injuries since it was introduced in 1988, the company reports. The product had been considered a banked human tissue until 1996 when the FDA announced that manipulated autologous cell-based products used for structural repair or reconstruction required regulatory oversight. Genzyme says it applied for regulatory approval of Epicel in 1999.